MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION TRAPEZOID RX; LITHOTRIPTOR, BILIARY MECHANICAL

Model Number M00510870

Device Problem Premature Activation (1484)

Patient Problem Insufficient Information (4580)

Event Date 04/11/2021

Event Type  Injury  

Manufacturer Narrative

(b)(4).Although the suspect device has been received, the evaluation has not been completed.Therefore, the cause of the reported malfunction has not been determined.Upon completion of the failure analysis of the complaint device, if there is any further relevant information from that review, a supplemental mdr will be filed.

Event Description

It was reported to boston scientific corporation that a trapezoid rx basket was used in the bile duct during an endoscopic retrograde cholangiopancreatography (ercp) procedure performed on (b)(6) 2021.During the procedure, the tip of the basket prematurely detached after lithotripsy and became stuck in the bile duct.The procedure was completed via an unknown alternate method or device.There were no patient complications reported as a result of this event.It was reported that the patient fully recovered.Boston scientific has been unable to obtain additional information regarding the event to date, despite good faith efforts.

Manufacturer Narrative

Block h6: device code a150103 captures the reportable event of tip premature deployment.Block h10: only the distal tip of the basket was returned for analysis.No visual issues or abnormalities were observed in the tip.Wire marks was found in the tip, evidence that it was properly attached prior to the failure.The reported event was confirmed.Based on all available information, it is most likely that procedural or anatomical factors encountered during the procedure could have affected the device performance and its integrity.Handling and manipulation of the device during its use, in addition to the use of the other device, can lead to the tip to prematurely detached.Procedural factors such as user technique/handling or excessive force applied to the handle to retract the basket could have caused the tip to detach prematurely.Therefore, the most probable root cause is adverse event related to procedure.A review of the device history record (dhr) confirmed that the device met all material, assembly, and product specifications at the time of release to distribution.A labeling review was performed and, from the information available, this device was used per the instructions for use (ifu)/product label.

Event Description

It was reported to boston scientific corporation that a trapezoid rx basket was used in the bile duct during an endoscopic retrograde cholangiopancreatography (ercp) procedure performed on (b)(6) 2021.During the procedure, the tip of the basket prematurely detached after lithotripsy and became stuck in the bile duct.The procedure was completed via an unknown alternate method or device.There were no patient complications reported as a result of this event.It was reported that the patient fully recovered.Boston scientific has been unable to obtain additional information regarding the event to date, despite good faith efforts.

• Brand Name: TRAPEZOID RX
• Type of Device: LITHOTRIPTOR, BILIARY MECHANICAL
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; 300 boston scientific way; marlborough MA 01752
• MDR Report Key: 11793875
• MDR Text Key: 249620263
• Report Number: 3005099803-2021-02030
• Device Sequence Number: 1
• Product Code: LQC
• UDI-Device Identifier: 08714729296386
• UDI-Public: 08714729296386
• Combination Product (y/n): N
• PMA/PMN Number: K040447
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup
• Report Date: 06/17/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 11/09/2021
• Device Model Number: M00510870
• Device Catalogue Number: 1087
• Device Lot Number: 0026325611
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/28/2021
• Initial Date Manufacturer Received: 04/12/2021
• Initial Date FDA Received: 05/07/2021
• Supplement Dates Manufacturer Received: 05/21/2021
• Supplement Dates FDA Received: 06/17/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention